Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 780 - 799)



  Q780  John Austin: Can I raise the issue of Seroxat and your knowledge and involvement. In 1998, I believe you were on the advisory board of GlaxoSmithKline or SmithKline Beecham, as it was at the time.

  Professor Sir Alasdair Breckenridge: No, let me just clarify that. From 1992 to 1997 I was a member of a scientific advisory committee of SmithKline. I resigned from that in 1997. This had been an extremely valuable exercise for my development in medicines regulation. We did not discuss specific products on that board; it was a matter of the larger picture of industry. I resigned from that in 1997 and this post had been taken up with the full cognisance of the then MCA. I discussed this with the MCA and I acted in a totally appropriate manner with respect to the decisions that I was party to there and in drugs and medicines regulation.

  Q781  John Austin: I was not suggesting otherwise. My question was whether you were aware or whether the company made you aware at the time of any testing that they were doing in relation to Seroxat and the use of Seroxat for children.

  Professor Sir Alasdair Breckenridge: We never discussed any medicines at all. That was never part of the remit of the scientific advisory board.

  Q782  John Austin: It is clear now that the company were aware of some negative results, particularly in terms of withdrawal. Were those ever communicated to you either in your role with SmithKline Beecham or subsequently in your role with the Committee on Safety of Medicines or the MHRA?

  Professor Sir Alasdair Breckenridge: With respect to me, as I have said already, certainly not and perhaps Dr Raine might like to answer the question about the communications to the Agency, if that is your wish.

  Q783  John Austin: I also note that we do not have Dr Ian Hudson with us this morning, although he was listed as one of the witnesses. Is there a reason why not?

  Professor Sir Alasdair Breckenridge: Yes, Dr Hudson is one of our delegates at the CHMP, the Committee on Human Medical Products at the EMEA and he is there today. He is fulfilling a different role for the Agency down there.

  Q784  John Austin: Would he have been able to answer the questions and would he have been aware?

  Professor Sir Alasdair Breckenridge: I cannot answer that on his behalf.

  Q785  John Austin: What was his role at that time?

  Professor Sir Alasdair Breckenridge: I cannot answer that question. I do not know that.

  Q786  Chairman: He is a colleague in the Agency—

  Professor Sir Alasdair Breckenridge: He is the head of licensing in the Agency.

  Q787  Chairman: Obviously he played a very key role in this respect and you have no knowledge of what that role was? You have not discussed it with him at all?

  Professor Sir Alasdair Breckenridge: No, I have not discussed it with him. He was appointed to the Agency in 2000 because he was the best candidate for the job to head up the Licensing Division.

  Q788  Chairman: And in advance of today's session, where no doubt you would have anticipated that this issue would have been raised, you have not discussed the possible involvement he may or may not have had?

  Professor Sir Alasdair Breckenridge: I have not discussed that with Dr Hudson at all. I do not know whether any of my colleagues have, but I have not.

  Q789  Dr Taylor: Would you be expected to be aware of everything that goes on in, for example, the expert working groups because we are told quite clearly that the expert working group on SSRIs was given evidence more than 18 months ago that withdrawal did cause suicidal hostility. Is it beyond the possibility of a job as large as yours to keep tabs on absolutely everything that goes on?

  Professor Sir Alasdair Breckenridge: Well, it is, but I have an interest in the field, having served on the Committee on Safety of Medicines, and I am aware of the recommendations as they went through, but I was not a member of the working group and it was not my role to be at them.

  Dr Taylor: So we really have not got anybody here who can answer that specific question?

  Q790  John Austin: I think it would have been useful if Dr Hudson had been here because, as far as I understand, he was at SmithKline Beecham and his department was responsible for the collection of adverse reaction information such as there was with Seroxat.

  Professor Sir Alasdair Breckenridge: Yes, I know that, but I—

  Q791  John Austin: So he would have been a very key witness.

  Professor Sir Alasdair Breckenridge: But I have not discussed that with Dr Hudson.

  Q792  John Austin: So you must admit that it is very unfortunate he is not with us today?

  Professor Sir Alasdair Breckenridge: Well, I apologise for that, but I think there was some confusion about who was going to attend and I think the Clerk was told that this was where Dr Hudson was going to be.

  Q793  Chairman: It is a little bit strange then with an issue as sensitive as this that there appears to have been no discussion within the Agency. Does Professor Woods want to come in at this point?

  Professor Woods: Yes, I would like to answer that because I do have some information which might be helpful to you. As Chief Executive, I have discussed with Dr Hudson his previous role within GSK in relation to the specific question of Seroxat and he assures me that he has had no direct personal involvement in those safety issues. However, because of his role within the company, we agreed, and have since scrupulously observed, that he should have no role within the Agency in any decision-making concerned with Seroxat.

  Q794  Chairman: And this was not communicated to Sir Alasdair?

  Professor Woods: I would regard it as an executive matter. I frequently do discuss issues with Sir Alasdair, but it is something I would consider, as Chief Executive, as my responsibility.

  Q795  John Austin: Presumably, Sir Alasdair, you were aware that the CSM had an expert working group which we now know reported in December looking at some of these issues?

  Professor Sir Alasdair Breckenridge: Yes.

  Q796  John Austin: In October you appeared on a Panorama programme in which you said that SSRI antidepressants did not cause suicidal behaviour in adults.

  Professor Sir Alasdair Breckenridge: Yes.

  Q797  John Austin: That statement at that time was completely at variance with the findings of the expert working group which reported two months later.

  Professor Sir Alasdair Breckenridge: No, with all respect, what the expert working group reported were two things. Firstly, in May 2003, we said that with respect to children there was an increase in suicidal ideation in children and no benefits, and that was May 2003. In 2004, the results of the expert working group said that whilst the SSRIs were clearly beneficial in adults, there was no evidence of increased suicide or suicidal thoughts compared to the times before the patients took the medicines. This was highlighted by the large studies which had been undertaken, three large studies, using the GPRD database, comparing SSRIs with the tricyclic antidepressants and there was no increase in suicidal behaviour due to the SSRIs. My own belief is that clearly in depression suicide is a huge problem. When the patient starts to take SSRIs, there is a period of time before benefit takes place and in that time before benefit takes place the patient is at great risk of suicide and this is a time when there must be intense monitoring and great care taken of the patient.

  Q798  John Austin: Could I also ask you in relation to this that after the report was published the MHRA informed doctors, following the report, that SSRIs were effective medicines in the treatment of depression and anxiety conditions. Now, nobody is disputing that, but do you not think that that required some qualification both in relation to the expert working group's report and also into the lack of evidence of the efficacy of the products in treating mild depression?

  Professor Sir Alasdair Breckenridge: Sorry, maybe I am not picking this up, but you have quoted the results of the expert working group quite rightly and this is the line which we have consistently followed. Perhaps there is something else in your question which I do not understand.

  Q799  John Austin: Well, after the report, my understanding is that your information to doctors merely stated that these are effective medicines in the treatment of depression and anxiety and did not have any qualification to that.

  Professor Sir Alasdair Breckenridge: Yes, it did, it had qualifications. What the expert working group did was to look at three issues about antidepressants: firstly, the question of withdrawal; secondly, the question of suicidal ideation; and, thirdly, the question of dose. The problem of withdrawal has been well known with antidepressants, especially Seroxat, and I happen to have before me the information sheet, the data sheet which we published, which the MCA published in 1990 when Seroxat was first licensed. If I can just read it to you, it says, "As with many psychoactive medicines, it may be advisable to discontinue therapy gradually as abrupt discontinuation may lead to symptoms, such as dizziness, sensory disturbances, sleep disturbances, agitation or anxiety, nausea, sweating and confusion". That was in 1990. We returned to that in 1993 in our journal Current Problems in Pharmacovigilance and we published an article on this again in 2000, so this is an issue which we have worried about and kept under review for a long time. The second issue which came up at the expert working group was suicidal thoughts to which you have referred already and the third issue was that of dose. If I return to the data sheet in 1990, the data said that the recommended dose was 20 milligrams and in some patients if it was necessary to increase the dose, this should be done gradually and that is still what the data sheet says today.

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